Clinical Trials Register

Summary
EudraCT Number:	2017-004514-25
Sponsor's Protocol Code Number:	SEDISTRESS
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-06-20
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-004514-25

A.3

Full title of the trial

EFFICACY AND SAFETY OF THE ADMINISTRATION OF THE PASSIFLORA EXTRACT FOR BENZODIAZEPINE WITHDRAWAL IN INSTITUTIONALIZED OLDER ADULTS : CLINICAL TRIAL PHASE III.

EFICACIA Y SEGURIDAD DE LA ADMINISTRACIÓN DEL EXTRACTO DE PASIFLORA EN LA DESHABITUACIÓN A BENZODIACEPINAS EN MAYORES INSTITUCIONALIZADOS: ENSAYO CLÍNICO FASE III.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

ADMINISTRATION OF THE PASSIFLORA EXTRACT FOR BENZODIAZEPINE WITHDRAWAL IN INSTITUTIONALIZED OLDER ADULTS

ADMINISTRACIÓN DEL EXTRACTO DE PASIFLORA EN LA DESHABITUACIÓN A BENZODIACEPINAS EN MAYORES INSTITUCIONALIZADOS

A.3.2

Name or abbreviated title of the trial where available

SEDISTRESS

A.4.1

Sponsor's protocol code number

SEDISTRESS

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Nutrición Medica S.L.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Nutrición Medica S.L.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Nutrición Medica S.L.
B.5.2	Functional name of contact point	Marisa Marquez
B.5.3	Address:
B.5.3.1	Street Address	C/ Arequipa nº1
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28043
B.5.3.4	Country	Spain
B.5.6	E-mail	marisa.marquez@nutricion.medica.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Sedistress
D.2.1.1.2	Name of the Marketing Authorisation holder	Nutrición Medica S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Sedistress
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Passiflora
D.3.9.1	CAS number	8000041-61-4
D.3.9.3	Other descriptive name	PASSIFLORA EXTRACT
D.3.9.4	EV Substance Code	SUB14780MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	Yes
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

benzodiazepines withdrawn

Deshabituación a benzodiacepinas

E.1.1.1

Medical condition in easily understood language

benzodiazepines withdrawn

Deshabituación a benzodiacepinas

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10004477
E.1.2	Term	Benzodiazepine dependent
E.1.2	System Organ Class	100000004873

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10048013
E.1.2	Term	Withdrawn
E.1.2	System Organ Class	100000004873

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% after 10 weeks of treatment

Comparar el porcentaje de pacientes que logra una reducción igual o superior del 50% en la dosis de benzodiacepinas a las 10 semanas de tratamiento.

E.2.2

Secondary objectives of the trial

 To compare the anxiety according to Hamilton Scale between both group after 5,10 weeks and 6 months of treatment
 To analyse the quality of life according to Euroqol 5D between both group after 5,10 weeks and 6 months of treatment
 To evaluate the cognitive state according to minimental test between both group after 5,10 weeks and 6 months of treatment
 To compare the sleep quality according to Pittsburgh questionnaire between both group after 5,10 weeks and 6 months of treatment
 To evaluate the funtional state according to Barthel Index between both group after 10 weeks and 6 months of treatment
 To compare the number of falls between both groups
 To analyse the side effect detected between both groups

 Comparar la ansiedad según la escala Hamilton entre los dos grupos a las 5, 10 semanas y a los 6 meses tras el inicio del tratamiento.
 Analizar la calidad de vida referida por los participantes según la escala Euroqol 5D a 5, 10 semanas y a los 6 meses tras el inicio del tratamiento.
 Evaluar el estado cognitivo entre ambos grupos utilizando el Test minimental a las 5, 10 semanas y a los 6 meses tras el inicio del tratamiento.
 Comparar la calidad del sueño según el cuestionario Pittsburg a las 5, 10 semanas y a los 6 meses tras el inicio del tratamiento.
 Analizar la evaluación funcional del paciente según el índice Barthel a las 10 semanas y a los 6 meses tras el inicio del tratamiento.
 Comparar el número de caídas entre ambos grupos.
 Analizar los efectos secundarios detectados entre los pacientes del grupo pasiflora y grupo control.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age > 65 years old
2. Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent)
3. Capable of giving consent and to answer the questionnaires according to researcher criteria

1. Edad >65 años.
2. Dosis estable de benzodiacepina en los últimos 3 meses con un límite en la dosis de loracepam 4 mg/día (o equivalente según Anexo Equivalencia fármacos).
3. Capacidad para comprender y firmar el documento "consentimiento informado" y para completar o contestar de forma fiable a los cuestionarios del estudio a criterio del investigador.

E.4

Principal exclusion criteria

1. Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).
2. Acute confusional syndrome at the inclusion
3- Panic disorder
4. Obsesive-compulsive disorder
5. Any type of psycosis or bipolar disorder
6. Severe Parkison disease diagnosed
7. Current or past diagnosis of epilepsia
8. Recent stroke (last month)
9. Thyroid disorders not controlled or uncompensated
10. Alteration of deglutition
11. Previous drugs or alcohol abuse
12. Hospitalization (more than 24 hours) during the last month
13. Complex priority treatment (dialisis, chemotherapy...)
14. Life expectation less than 1 year
15. Benzodiazepines therapeutic uses not for anxiety or insomnio

1. Demencia establecida moderada o grave (Test Minimental ≤ 20).
2. Síndrome confusional agudo en el momento de la inclusión.
3. Trastorno pánico.
4. Trastorno obsesivo-compulsivo
5. Cualquier forma de psicosis o trastorno bipolar
6. Enfermedad de Parkinson grave diagnosticada
7. Paciente con diagnóstico presente o pasado de epilepsia
8. Ictus reciente (mes anterior)
9. Alteración tiroidea no controlada o descompensada.
10. Problemas importantes de deglución a criterio del investigador
11. Historial de abuso o dependencia a drogas o alcohol
12. Ingreso hospitalario en el último mes superior a 24 horas
13. Tratamiento complejo prioritario a juicio del médico responsable (ej., diálisis, quimioterapia, etc.)
14. Expectativa vital inferior al año
15. Tratamiento con benzodiacepinas por causas distintas a la ansiedad y/o insomnio

E.5 End points

E.5.1

Primary end point(s)

Dose of benzodiazepines

Dosis de benzodiacepinas diaria que recibe el paciente

E.5.1.1

Timepoint(s) of evaluation of this end point

After 10 weeks of treatment

10 semanas del inicio del tratamiento

E.5.2

Secondary end point(s)

Hamilton Rating Scale for Depression
Euroqol-5D (EQ-5D)
Mini-Mental State Examination
Falls
Pittsburg questionnaire
Barthel index
Adverse events

Escala Hamilton
Euroqol-5D (EQ-5D)
Test de Mini-mental
Caídas
Cuestionario Pittsburg
Índice de Barthel
Eventos adversos

E.5.2.1

Timepoint(s) of evaluation of this end point

5 and 10 weeks and 6 months after the begining of the treatment

5 y 10 semanas y 6 meses tras inicio del tratamiento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Ultima paciente ultima visita

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

108

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

108

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-08-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-05

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2019-12-27

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